Carol Emerson

FDA Filings

This page includes the latest FDA filings for Carol Emerson. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010246951
FEI Number3010246951
NameCarol Emerson
Owner & OperatorShenzhen Xinrun Electric Appliances Co Ltd
Contact AddressShenzhen Boan District, Shajing Street, Wanan Rd, Changxing Technology Park, No1
Shenzhen CN-44 Guangdong 518104 CN
US Agent
Importing Logistics Registration
ImporterCOTHERA LLC
Address5204 Tennyson Parkway, suite 100
Frisco, TX 75034 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2885 Loker Ave E
Carlsbad, CA 92010 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3007420696
FEI Number3007420696
NameCarol Emerson
Owner & OperatorFastForm Research Limited
Contact Address4 Lear Avenue Airport Business Park
Killowen IE-WD Waterford X91 D785 IE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2885 Loker Ave E
Carlsbad, CA 92010 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3015960622
FEI Number3015960622
NameCarol Emerson
Owner & OperatorBreg Inc
Contact Address2885 Loker Ave E
Carlsbad CA 92010 US
Official Correspondent
  • Carol Emerson
  • x-760-7955823-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2885 Loker Ave E
Carlsbad, CA 92010 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Carol Emerson [FastForm Research Limited]
FastForm AFO Ankle & Foot Orthosis2019-12-16
Carol Emerson [Breg Inc]
Vertalux2015-05-17
Carol Emerson [Breg Inc]
Ortholux2015-05-17
Carol Emerson [Breg Inc]
Ninja2015-05-17
Carol Emerson [Breg Inc]
Lumbolux2015-05-17
Carol Emerson [Breg Inc]
Centron2015-05-17
Carol Emerson [Breg Inc]
Ace2015-05-17
Carol Emerson [Shenzhen Xinrun Electric Appliances Co Ltd]
VPULSE SYSTEM2013-03-04
Carol Emerson [FastForm Research Limited]
FastForm Wrist Cast2008-12-01
Carol Emerson [FastForm Research Limited]
FastForm SCB VERSI Strip2008-12-01
Carol Emerson [FastForm Research Limited]
FastForm SCB VERSI Sheet2008-12-01
Carol Emerson [FastForm Research Limited]
FastForm SCB Universal Gutter Multifunctional Orthosis2008-12-01
Carol Emerson [FastForm Research Limited]
FastForm SCB Thumb Spica Multifunctional Orthosis2008-12-01
Carol Emerson [FastForm Research Limited]
FastForm SCB Tension Straps2008-12-01
Carol Emerson [FastForm Research Limited]
FastForm SCB Short Arm Multifunctional Orthosis2008-12-01
Carol Emerson [FastForm Research Limited]
FastForm SCB Immobilizer2008-12-01
Carol Emerson [FastForm Research Limited]
FastForm SCB Hook & Loop refresh Strips2008-12-01
Carol Emerson [FastForm Research Limited]
FastForm SCB Hand-based thumb Spica Orthosis2008-12-01

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